Overview of Licensing Process 2 of 5 

The Strategy:

The strategy for reviewing submissions will vary with the submission but in general the 

reviewer follows a common path. The reviewer needs to assess the priority of the 

submission; identify prior correspondence regarding the issue; consult the appropriate 

regulations, guidelines and literature; determine which other sections need to be 

consulted and what other actions need to be performed. The reviewer then responds by 

explicitly stating the outcome of the review, making recommendations based on the 

submitted information, and suggesting ways to remedy deficiencies in the submitted 

material. It is important for the reviewer to view the process as a cooperative effort 

between the firm and the agency in order to maintain high quality veterinary biologics 

and diagnostic kits. 

The licensing process is an accumulation of data and information that ideally follows the 

process described in VSM 800.50 and provides the necessary support to justify licensure. 

The firm is responsible for carrying out the studies, documenting them, and assuring they 

were performed as stated, while the reviewer is responsible for assuring the submitted 

material meets the regulatory requirements. The final product, when ready for licensing, 

must stand on the merit of the submissions and have appropriate justification for any 

variances allowed. 

Communications Official and Unofficial:

Communication via letter, on APHIS Forms, and as part of the official program at the 

Public Meeting are official forms of communication. All other interactions, such as 

phone calls, e-mail, or face-to-face meetings are unofficial until followed by official 

correspondence. When an unofficial communication has taken place, it is common 

practice to have the firm make a formal written request, asking for an official response.

One of the most important parts of the reviewer’s job is to prepare complete, explicit 

written responses to submissions. Response letters should include adequate detail to 

stand alone without referring to the incoming submission. They should enable the 

submitter to understand the basis for a decision, describe the limitations of that decision, 

and educate the submitter regarding CVB regulations and policy. Avoid vague phrases 

such as “This submission is acceptable for the purpose intended.” 

Regardless of the type of communication, it is essential to maintain notes and logs of 

important discussions and to ensure that copies of these records are uploaded to the mail 

log. In particular, use caution when communicating by email. It is a convenient 

mechanism to interact with your firms, but it bypasses the review to which official 

correspondence is subjected. Try to use email only for short, simple requests or 

notifications. Avoid providing regulatory guidance by email. If an email string contains 

information that should be included in the licensing file, make a pdf copy and upload it to 

the related mail log. If in doubt about the relevance of an email to the licensing file, 

Overview of Licensing Process 4 of 5 

standard, or study results that clearly are not acceptable (in which case it is not worth the 

statistician’s time to analyze). Reviewers also should determine whether electronic data 

files (if applicable) were included and should request any missing items from the firm as 

soon as possible. 

If a submission requires statistical analysis, however, it is important to send it to Statistics

as soon as you have completed a preliminary review.. If you question whether a 

particular submission should be reviewed by Statistics, feel free to consult with one of the 

statisticians prior to routing to Statistics.. 

 

Use of Other CVB Support: 

The reviewer may request an opinion on a particular submission from other personnel 

within CVB (e.g., the designated Agent Expert for the antigen being considered, 

laboratory personnel, IC personnel). It is common for testing protocols (e.g., Section V, 

Outline of Production) to be reviewed by laboratory personnel. Other opinions may be 

sought, depending on the reviewer’s discretion. When requesting input from other CVB 

personnel, the applicable part(s) of the submission should be forwarded with a cover 

letter or routing comment that explains the review requested. It is often useful to set a 

deadline for review (e.g., “please reply by (two weeks) if you plan to comment on this”) 

to keep the submission moving forward. 

When reviewing submissions for split manufacture (i.e, products for further manufacture 

(FFM) and those final-use products containing FFM components), the reviewer should 

routinely consult the reviewer(s) responsible for the other firm(s) participating in the split 

manufacture before making any pivotal decisions.

Outside consults:

This is atypical but not unprecedented. The key in doing this is to realize that everything 

is confidential business information and needs to be kept that way. It is feasible to 

discuss things generically, but submissions must not be given to anyone outside the CVB 

without written permission from the submitter. 

Use of auxiliary opinions in final review: 

Always be aware that it is the reviewer who makes the final decision (and is liable for 

that decision) regarding the acceptability of a submission. Reviewers are expected to 

evaluate the merits of the submission before accepting another person’s opinion. 

The content of the response letter should be written by the reviewer, and should not be 

simply a collection of other documents, copy and pasted into a letter. If you agree with 

the opinions provided by others and wish to incorporate them into your response, 

paraphrase their comments in your own writing style. Use “cut and paste” judiciously. 

Do not forward auxiliary comments in their original format without express permission of 

the author.